MAUDE Adverse Event Report: ARTHREX, INC. DW ARTHROSCOPY FLUID MANAGEMENT DEV ARTHROSCOPE

Model Number DW ARTHROSCOPY FLUID MANAGEMENT DEV

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Joint Swelling (2356)

Event Date 05/21/2020

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation. The root cause of the event could not be determined from the information available and without device evaluation.

Event Description

It was reported during a knee arthroscopy the procedure went very normal and the pump functioned properly without overpressure. The pump was at the same level as the operative site. All readings were normal and there was no excessive fluid noticed from the knee. However after the procedure and before closing it was noticed the patients calf was extremely swollen and very hard due to compartment syndrome. A fasciotomy was performed with a four to five inch incision which released the pressure and pure saline came out. This made an immediate relief to the calf area and it soon went back to the same size as the calf on the other leg. The doctor closed up the incision and is confident the problem is resolved. The doctor believes the patient had a tear in the knee capsule which lead to the fluid leaking down to the calf. Additional information obtained 05/21/2020: the procedure was on the patient's right leg. The pump used with the tubing was ar-6480, serial number (b)(4). Both the pump and tubing will be returned for evaluation.

• Brand Name: DW ARTHROSCOPY FLUID MANAGEMENT DEV
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 10133011
• MDR Text Key: 194603859
• Report Number: 1220246-2020-01884
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083707
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: DW ARTHROSCOPY FLUID MANAGEMENT DEV
• Device Catalogue Number: AR-6480
• Device Lot Number: 21811012
• Was Device Available for Evaluation?: Yes

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2018
• Is the Device Single Use?: No

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 06/09/2020 Patient Sequence Number: 1